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Completed

NCT Number: NCT03002077

Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
  • Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening
  • Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
  • If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion criteria

  • DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening
  • Lifetime history of meeting DSM-5 criteria for:
  • Schizophrenia spectrum or other psychotic disorder
  • Bipolar or related disorder
  • Major neurocognitive disorder
  • Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
  • Dissociative disorder
  • Posttraumatic stress disorder
  • MDD with psychotic features
  • Significant suicide risk, as judged by the Investigator.

Treatment and study plan

Rapastinel

Drug

Rapastinel pre-filled syringes for IV injections.

Primary outcomes

  1. The Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 52 Weeks

    An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Secondary outcomes

  1. Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+)

    Time frame: Baseline to 52 Weeks

    The BPRS+ is a subset of the BPRS that assesses 4 components of the BPRS+ related to the degree of psychosis: Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content assessed by the investigator using a 7-point scale ranging from 1=Not Present to 7=Extremely Severe for a total possible score of 0 (best) to 28 (worst). A negative change from Baseline indicates improvement.

  2. Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS)

    Time frame: Baseline to 52 Weeks

    The Clinician Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during active dissociative experiences composed of 23 subjective self-reported and 5 objective observer-reported ratings, each scored from 0 (not at all) to 4 (extremely). Only the 23 subjective items will be collected and analyzed. The sum of each of the 23 subjective items was used for a total score of 0-92. A negative change from Baseline indicates improvement.

Sponsors and collaborators

Lead sponsor

Naurex, Inc, an affiliate of Allergan plc

Industry

Registry information

Official study title

An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 23, 2016
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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